The containment performance of the GEA Coater, described as a “new generation” device capable of both continuous and batch film coating, was assessed during three phases of operation and discussed in a peer-reviewed journal
通常,当评估新压片机时,首先要问的一个问题是压制站数量。压片机可生产的片剂数量对所有固体剂型制造商来说都是关键参数。此外,对于单出料旋转式压片机,这一数量可通过压制站数量乘以旋转速度和运转时间(单位为分钟)计算出来。例如,拥有 25 个压制站的压片机,以 120 转每分钟的转速旋转,则每小时产生 180,000 片。
We at GEA, in collaboration with MSD, a tradename of Merck & Co., Inc. (Kenilworth, NJ, USA), recently conducted a successful robustness trial on GEA’s ConsiGma® CDC 50 Continuous Direct Compression system for a period of 120 hours. The positive outcome highlights the suitability of the technology — known as continuous manufacturing — for the efficient completion of campaigns that formerly involved longer and more complex batch processes.
Designed to gently and accurately deposit controlled amounts of coating materials onto tablet cores — even if they are hygroscopic or friable — the high-performance GEA coater technology is able to process both small and large quantities of tablets at very high suspension application rates.
煤矿工人曾经依靠笼中的鸟来检测空气中的毒素,作为危险情况的早期指标。GEA 将这一概念带入了 21 世纪,并创建了 Digital Canary,以确保使用高活性成分生产口服固体制剂的操作员的健康和安全。
GEA 为制药行业提供具有混合、搅拌、造粒、干燥、造丸和包衣功能的高级固体制剂处理设备已有 50 余年的历史。公司的产品组合无比伦比,高级制药技术专员 Harald Stahl 简述了 GEA 领先市场的技术和设备。
近来年,随着技术的突飞猛进,我们的造粒技术不断升级,因此可为每一种产品结构和生产组合提供可靠的最优解决方案。GEA 一直都是这一领域的领先者,我们不断革新升级,拼尽全力,只为针对您的造粒应用提供完美解决方案。
Innopharma Labs 提供具有成本效益的可靠 PAT 分析仪,为稳定的制造工艺提供支持。Innopharma Labs 的产品帮助客户进一步理解其制造工艺,进而帮助减少扩展时间、降低产品损失并改进良率。Eyecon™ 三维颗粒表征器为造粒、碾磨和成球等工艺提供了在线和实时表面形态学、形状和粒度等信息。
Optimizing the granulation process — the most important unit operation during the production of pharmaceutical oral solid dosage forms — is not only a critical aspect of operational excellence, it also plays a major role in preventing downstream compression problems.
The use of microwaves during high-shear wet granulation and drying in a single-pot processor is shown to be more effective and efficient than gas-stripping.
GEA 的喷雾干燥和配方专业技术可以实现气动颗粒粒度和流动特性的精确操控。借助以上技术,现在能够比以前更轻松高效生产出能在空气中自由流动的药物微粒,用于吸入式治疗。作为一种给药方法,吸入治疗尤其适用于摄入治疗时容易导致品质下降的商业化生物的化合物,例如激素、肽类和蛋白质。
The overall materials handling concept for potent APIs is the controlling factor in determining the containment performance of the entire installation. There are two basic choices: stainless steel or disposable systems.
实验室中合成医药蛋白用于制药生产。许多 DNA 重组工艺修改微生物的基因之后将其作为宿主细胞(细菌、酵母或哺乳动物细胞),特定条件下生产无法自然形成的生物制品。胰岛素是第一种治疗性蛋白质,从上世纪 20 年代开始用于糖尿病的治疗。